Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2025-12-29 @ 9:16 AM
Study NCT ID:
NCT05084950
Status:
UNKNOWN
Last Update Posted:
2021-10-20
First Post:
2021-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Informing the Population of Their Level of Protection Against COVID-19 in Monaco: a Prospective Study (MonaVacc)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-10-19', 'studyFirstSubmitDate': '2021-10-19', 'studyFirstSubmitQcDate': '2021-10-19', 'lastUpdatePostDateStruct': {'date': '2021-10-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Covid-19 Neutralizing Antibodies Measurment', 'timeFrame': '24-month period', 'description': 'Inform any individual who has been infected with or vaccinated against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) have about their level of immune protection, through a bi-annual follow-up'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['SARS-CoV-2', 'COVID-19', 'Vaccines', 'Antibody']}, 'descriptionModule': {'briefSummary': 'Vaccines against the coronavirus type 2 causing severe acute respiratory syndrome Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) have been created in a short period of time due to the rapid spread of the virus. These vaccines use different and sometimes innovative technologies, such as the use of ribonucleic acid (RNA), or a non-replicating viral vector. Efficacy ranging from 70-90% in the first weeks after the second injection of these vaccines has been reported, with side effects whose causality remains to be determined.', 'detailedDescription': 'Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This is a single-centre prospective observational study in the general population of the Principality of Monaco, attending the community public health center of Monaco, for Covid testing and/or vaccination.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant must live in the Principality of Monaco\n* Deliver a written consent to participate to the study\n* And/Or Have been infected with SARS-CoV-2\n* And/Or Have been, or are about to be, vaccinated against SARS-CoV-2\n\nExclusion Criteria:\n\n\\- None of the above'}, 'identificationModule': {'nctId': 'NCT05084950', 'acronym': 'MonaVacc', 'briefTitle': 'Informing the Population of Their Level of Protection Against COVID-19 in Monaco: a Prospective Study (MonaVacc)', 'organization': {'class': 'OTHER', 'fullName': 'Centre Scientifique de Monaco'}, 'officialTitle': 'Informing the Population of Their Level of Protection Against COVID-19 in Monaco: a Prospective Study (MonaVacc)', 'orgStudyIdInfo': {'id': 'PRO_CSM_02_2021'}}, 'contactsLocationsModule': {'locations': [{'zip': '98000', 'city': 'Monaco', 'status': 'RECRUITING', 'country': 'Monaco', 'contacts': [{'name': 'Eric VOIGLIO, MD, PhD', 'role': 'CONTACT', 'email': 'evoiglio@gouv.mc', 'phone': '+37798984850'}, {'name': 'Thomas ALTHAUS, MD, PhD', 'role': 'CONTACT', 'email': 'talthaus@gouv.mc'}, {'name': 'Eric VOIGLIO, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Thomas ALTHAUS, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Herve RAPS, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Olivier DEJOUX, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Patrick RAMPAL, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Centre National de Depistage - Espace Leo Ferre', 'geoPoint': {'lat': 43.73718, 'lon': 7.42145}}], 'centralContacts': [{'name': 'Eric VOIGLIO, MD, PhD', 'role': 'CONTACT', 'email': 'evoiglio@gouv.mc', 'phone': '+37798984850'}, {'name': 'Thomas ALTHAUS, MD, PhD', 'role': 'CONTACT', 'email': 'talthaus@gouv.mc', 'phone': '+37798984850'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Scientifique de Monaco', 'class': 'OTHER'}, 'collaborators': [{'name': 'Department of Health Affairs, Monaco', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}